Cannabidiol for Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Stem Cell Transplantation

Phase 1

• Conditions: Graft Versus Host Disease
• Interventions: Drug: Oral Cannabidiol

• Registration Number: NCT01385124
• Lead Sponsor: Rabin Medical Center

Brief Summary

Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing allogeneic hematopoietic cell transplantation. Despite prophylactic measures, the incidence of acute GVHD is estimated at 40-60% among patients receiving transplant from HLA-identical sibling donors, and may even reach 75% in patients receiving HLA-matched unrelated transplants. More effective prevention and treatment strategies are needed.

The immunomodulatory and anti-inflammatory properties of Cannabinoids have been shown in animal models of various inflammatory diseases including multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.

Cannabidiol is a major non-psychoactive cannabinoid, which has potent anti-inflammatory and immunosuppressive effects.

As such, it may reduce the incidence and severity of GVHD after allogeneic stem cell transplantation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-06-28
• Study First Posted: 2011-06-29
• Status Verified: 2012-09
• Study Start: 2012-09
• Last Update Submitted: 2015-06-18
• Last Update Posted: 2015-06-19
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients undergoing allogeneic stem cell transplantation.
2. No previous history of psychosis. -

Exclusion Criteria

1. Previous history of psychosis.
2. Consumption of cannabis during the last 2 moths before transplantation. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral Cannabidiol	Oral Cannabidiol	Oral Cannabidiol 10 mg twice daily will be given from conditioning starting day and until day +30 after allogeneic transplantation. Dose can be doubled every 7 days if no significant side effects documented.

Primary Outcome Measures

Name	Time	Method
Overall percentage of patients with acute GVHD at day 100 post-transplant	day 100

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with grade III/IV acute GVHD at day 100 post-transplant	day 100

Trial Locations

Locations (1)

Davidoff Cancer Center, Beilin hospital, Rabin medical center; 🇮🇱 Petach Tikva, Israel